NovoNorm 0.5mg (repaglinide)

NovoNorm tablets contain the active ingredient repaglinide, which is an antidiabetic medicine used to help control blood sugar levels in people with type 2 (non-insulin dependent) diabetes.

What is repaglinide used for?

Type 2 (non-insulin dependent) diabetes.

Repaglinide can be used on its own to treat people with type 2 diabetes whose blood sugar has not been controlled sufficiently by diet, exercise and weight loss alone.

Repaglinide can also be used in combination with another antidiabetic medicine called metformin, for people with type 2 diabetes whose blood sugar is not controlled using metformin alone. Since metformin mainly helps reduce blood sugar levels between meals (fasting blood sugar levels) and repaglinide reduces mealtime blood sugar levels, the combination of the two provides an additive effect on blood sugar control.

How does repaglinide work?

People with diabetes have a deficiency or absence of a hormone produced by the pancreas called insulin. Insulin is the main hormone responsible for the control of sugar in the blood. In type 2 diabetes the pancreas does not produce sufficient insulin. The cells of the body are also resistant to the low levels of insulin circulating in the blood. Insulin would normally make the cells remove sugar from the blood. This means in type 2 diabetes blood sugar levels can rise too high.

Repaglinide works by acting on the cells in the pancreas that produce insulin. These cells are called beta cells. Repaglinide causes the beta cells to produce more insulin.

Repaglinide is taken before meals to enhance insulin production during the meal. The enhanced insulin production starts about 30 minutes after taking the dose of repaglinide. This results in a blood sugar lowering effect throughout the meal, as would occur naturally in people who don't have diabetes.

How do I take repaglinide?

Repaglinide tablets should usually be taken around 15 minutes before a main meal. However, if necessary, you can take your dose up to 30 minutes before the meal or just before eating.

If you skip a meal, you should also skip your repaglinide dose for that meal. Equally, if you have an extra meal, you should add an extra repaglinide dose for that meal.

What should I know before taking repaglinide?

Your doctor may want you to check the level of sugar in your blood or urine from time to time while you are taking repaglinide. Make sure you discuss how to do this and how often with your GP, pharmacist or diabetes specialist.

Low blood sugar (hypoglycaemia) may occur as a side effect of repaglinide. This is more likely to occur if you take it with metformin or other antidiabetic medicines. It is important that you are aware of the symptoms of hypoglycaemia (these may include cold sweats, cool pale skin, tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, excessive hunger, temporary vision changes, headache or nausea) and what to do if you experience these symptoms. Discuss this with your GP, pharmacist or diabetes specialist. You should also be aware that the risk of hypoglycaemia is increased by strenuous physical exercise and drinking alcohol.

People who are taking antidiabetic tablets should only drink alcohol in moderation and accompanied by food. This is because alcohol can make your warning signs of low blood sugar less clear, and can cause delayed low blood sugar, even several hours after drinking.

Your ability to concentrate or react may be reduced if you have low blood sugar, and this can cause problems driving or operating machinery. You should take precautions to avoid low blood sugar when driving - discuss this with your doctor.

If you get an infection or fever, have an accident, or are under particular stress you should let your doctor know, because when the body is put under stress repaglinide may become less effective at controlling your blood sugar. In these cases your doctor may need to temporarily replace your treatment with insulin. You should also consult your doctor about your diabetes treatment if you are due to have surgery under a general anaesthetic, or if you get pregnant. In these situations blood sugar is normally controlled with insulin.

Who shouldn't take repaglinide?

People with type 1 (insulin dependent) diabetes.

People with diabetic keto-acidosis.

People with severely decreased liver function.

Women who are pregnant or breastfeeding.

The manufacturer has not studied this medicine in children aged under 18 years, elderly people aged over 75 years, or people with impaired liver function. For this reason the medicine is not recommended in these groups of people.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Repaglinide should be used with caution in

Weak or debilitated people.

People who are malnourished.

People with kidney problems.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of repaglinide during pregnancy has not been established, therefore it should not be used by pregnant women. Control of diabetes in pregnancy is usually achieved using insulin, because this provides a more stable control of blood sugar. Seek medical advice from your doctor if you get pregnant while taking this medicine.

Repaglinide may pass into breast milk. It should not be used by breastfeeding mothers. Seek further medical advice from your doctor.

What are the possible side effects of repaglinide?

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with repaglinide. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

Can I take other medicines with repaglinide?

Many medicines can affect blood sugar levels. It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

The blood sugar lowering effect of repaglinide may be enhanced or prolonged by the following medicines and these may therefore increase the chance of low blood sugar (hypoglycaemia). If you take any of these in combination with repaglinide your dose may need reducing:

large doses of salicylates, eg aspirin (small pain relieving doses do not normally have this effect)

trimethoprim or co-trimoxazole (should be avoided where possible in people taking repaglinide; blood sugar levels should be carefully monitored if trimethoprim is needed to treat an infection).

Beta-blockers, eg propranolol (including eye drops containing beta-blockers) can mask some of the signs of low blood sugar, such as increased heart rate and tremor. They may also prolong episodes of low blood sugar and impair recovery back to normal glucose levels.

The following medicines may increase blood glucose levels. If you start treatment with any of these your dose of repaglinide may subsequently need increasing:

asthma relievers (beta 2 agonists), eg salbutamol

corticosteroids, eg hydrocortisone, prednisolone

diuretics, especially thiazide diuretics, eg bendroflumethiazide

danazol

oestrogens and progestogens, such as those contained in oral contraceptives

thyroid hormones, eg thyroxine.

The following medicines may affect the blood level of repaglinide and so could change its effect at controlling blood sugar:

carbamazepine

phenobarbital

phenytoin

rifampicin

the herbal remedy St John's wort (Hypericum perforatum).

If you take any of these in combination with repaglinide, your blood sugar level should be monitored more frequently and your dose may need to be adjusted.